XXXXXXXXX XXXXXXXXXX XXXXXX (XX) 2020/528
ze xxx 14. xxxxx 2020,
xxxxxx xx xxxxxxxxx xxxxxxxxxx x Brazílii, Xxxx, Xxxxx Xxxxxx, Xxxxxxxxx xxxxxxx x Xxxxxxx xx xxxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxx xxx xxxxxxxxx xxxxxxxxx xxxxxxxxxx xxxxx xxxxx xxxxxxxxx x xxx, xxxxx x xxxxxx
(xxxxxxxx pod xxxxxx X(2020) 2103)
(Xxxx x xxxxxxxx xxx XXX)
XXXXXXXX XXXXXX,
x xxxxxxx xx Smlouvu x fungování Evropské xxxx,
x xxxxxxx xx xxxxxxxxxx Xxxx 2000/258/ES xx dne 20. xxxxxx 2000 x xxxxxx zvláštního xxxxxxxxx xxxxxxxxxxx za stanovení xxxxxxxx xxxxxxxxxx xxx xxxxxxxxxxx xxxxxxxxxxxxx testů xxx sledování účinnosti xxxxxxxxxx látek proti xxxxxxxxx&xxxx;(1), x zejména xx čl. 3 xxxx. 2 uvedeného xxxxxxxxxx,
xxxxxxxx k xxxxx xxxxxxx:
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(1) |
Xxxxxxxxxx 2000/258/XX xxxxxx xxxxxxxxx Xxxxxx xxxxçxxxx xx xxxxxxxx sanitaire xxx xxxxxxxx (dále xxx „XXXXX“) xx xxxxxxxxxxxx Nancy xxxx xxxxxxxx institut odpovědný xx xxxxxxxxx xxxxxxxx xxxxxxxxxx xxx xxxxxxxxxxx xxxxxxxxxxxxx xxxxx xxx xxxxxxxxx účinnosti očkovacích xxxxx xxxxx xxxxxxxxx. XXXXX xxxx nyní xxxxxxxxx do Xxxxxx xxxxxxxxx xx xxxxxxxx xxxxxxxxx xx x’xxxxxxxxxxxx, xx x’xxxxxxxxxxxxx xx xx xxxxxxx (xxxx xxx „ANSES“) ve Xxxxxxx. |
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(2) |
Xxxxxxxxxx 2000/258/XX xxxx xxxx stanoví, xx XXXXX xxxxxxx laboratoře xx xxxxxxx zemích, xxxxx xxxxxxxxxx žádost x xxxxxxxxx xx xxxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxx xxx xxxxxxxxx xxxxxxxxx xxxxxxxxxx xxxxx xxxxx xxxxxxxxx. |
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(3) |
Xxxxxxxxx xxxxx x Xxxxxxxx xxxxxxxxx xxxxxx x xxxxxxxxx xxxxxxxxxx „Núcleo xx Xxxxxxxxx xx Raiva xx Xxxxxxxxxxx xx Xxxxxxxxx Clínica x Xxxxxxxxx xx Instituto xx Ciências Xxxxxxxxxx xx Xxxxxxxxxxxx xx Xãx Paulo“. ANSES xxx tuto xxxxxxxxx xxxxxxxxxxx xxxxxxxxx hodnotící xxxxxx ze xxx 24. xxxxx 2019, xxxxxx xxxxxxxxxx Xxxxxx. |
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(4) |
Xxxxxxxxx xxxxx Číny xxxxxxxxx xxxxxx o xxxxxxxxx xxxx xxxxxxxxxx: „Xxxx Xxxx World Biologicals Xxxxxxxxxxxxxx Co., Ltd (Xxxxxx)“ x „Xxxxxx Xxxxxxx Diagnostic Center xx xxx Institute xx Animal Health xx xxx Xxxxxxxxx Xxxxxxx of Xxxxxxxxxxx Xxxxxxxx“. XXXXX xxx xxxx xxxxxxxxxx xxxxxxxxxxx xxxxxxxxx hodnotící xxxxxx xx xxx 24. xxxxx 2019, kterou xxxxxxxxxx Xxxxxx. |
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(5) |
Xxxxxxxxx orgán Xxxx předložil xxxxxx x opětovné xxxxxxxxx xxxx laboratoří: „National Xxxxxxxxx Xxxxxxxxxx xxx Xxxxxx Xxxxxx (Xxxxxxxxxx Xxxxxxxxxx xxx Xxxxxx xxx Xxxxxxxx Xxxxxxxxxx Xxxxxxxx)“ x „Centre xxx Xxxxxx Xxxxxxxx Xxxxx xx xxx Xxxxxxxxxx of Epidemiology xx xxx Xxxxxxxx Xxxxxxxxxx Xxxxxxxx Xxxxxxxxx xx the Xxxxxxx xx Xxxxxxxx Xxxxxxx Xxxxxxxx“. XXXXX xxx xxxx xxxxxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxxx zprávu xx dne 24. xxxxx 2019, xxxxxx xxxxxxxxxx Komisi. |
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(6) |
Příslušný xxxxx Xxxxx Xxxxxx předložil xxxxxx o xxxxxxxxx xxxxxxxxxx „Xxxxxx xxx Xxxxxxxx encephalitis XXX xxxxxxxxx xxxxxxxxxx of Xxxxxx and Xxxxx Xxxxxxxxxx Xxxxxx“. ANSES xxx xxxx laboratoř xxxxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxxx xx xxx 24. října 2019, xxxxxx předložila Xxxxxx. |
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(7) |
Xxxxxxxxx xxxxx Thajska xxxxxxxxx xxxxxx x xxxxxxxxx xxxxxxxxxx „Xxxxxxxx Xxxxxxxxx xx Animal Xxxxxx“. XXXXX xxx xxxx xxxxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxxx ze xxx 24. října 2019, xxxxxx předložila Xxxxxx. |
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(8) |
Xxxxxxxxx xxxxx Xxxxxxxxx xxxxx xxxxxxxxx xxxxxx x xxxxxxxx schválení xxxxxxxxxx „Centers xxx Xxxxxxx Xxxxxxx xxx Xxxxxxxxxx xx xxx Xxxxxx Laboratory“. ANSES xxx xxxx xxxxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxxx ze dne 24. xxxxx 2019, xxxxxx předložila Komisi. |
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(9) |
Tyto xxxxxxxxxx xx xxxxx xxxx xxx schváleny xx xxxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxx xxx xxxxxxxxx xxxxxxxxx xxxxxxxxxx xxxxx xxxxx xxxxxxxxx x xxx, xxxxx x xxxxxx. |
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(10) |
Xxxxxxxx xxxxxxxxx xxxxx rozhodnutím xxxx x souladu xx xxxxxxxxxxx Xxxxxxx výboru xxx xxxxxxxx, zvířata, xxxxxxxxx x xxxxxx, |
XXXXXXX XXXX XXXXXXXXXX:
Xxxxxx 1
X souladu x xx. 3 xxxx. 2 xxxxxxxxxx 2000/258/XX xx pro xxxxxxxxx xxxxxxxxxxxxx xxxxx xx xxxxxx sledování xxxxxxxxx xxxxxxxxxx xxxxx xxxxx xxxxxxxxx x xxx, xxxxx x xxxxxx xxxxxxxxx tyto xxxxxxxxxx:
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x) |
Xxxxxx de Xxxxxxxxx xx Xxxxx Xxxxxxxxxxx xx Xxxxxxxxx Clínica e Xxxxxxxxx xx Xxxxxxxxx xx Xxêxxxxx Biomédicas Xxxxxxxxxxxx xx Xãx Xxxxx Xx. Xxxx. Xxxxx Xxxxxxx, 1374, xxxx 225 05508-000 Xãx Xxxxx Xxxxxxxx |
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b) |
Sino Tech Xxxxx Xxxxxxxxxxx Pharmaceutical Xx., Xxx (Xxxxxxx) 29 Xxxxxxxx Xxxx Xxxx. Xxxxxxxxxx Medicine Xxxx, Xxxxxx Xxxxxxxx, Peking Xxxx |
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c) |
Xxxxxx Xxxxxxx Xxxxxxxxxx Xxxxxx Institute of Xxxxxx Health, Guangdong Xxxxxxx xx Xxxxxxxxxxx Xxxxxxxx 21 Xxxxxxxxxx Street, Xxxxxx Xxxxxxxx Xxxxxxxxx, Xxxxxxxxx Čína |
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x) |
National Xxxxxxxxx Xxxxxxxxxx for Xxxxxx Xxxxxx (Diagnostic Xxxxxxxxxx xxx Xxxxxx xxx Wildlife Xxxxxxxxxx Xxxxxxxx) Xxxxxxxxx Veterinary Xxxxxxxx Xxxxxxxxx, Xxxxxxx Xxxxxxx xx Agricultural Xxxxxxxx 666 Xxxxxxx West Road, Xxxxxxx Economy Development Xxxxxxxx, Xxxxxxxxx, Jilin, Čína |
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x) |
Xxxxxx xxx Xxxxxx Xxxxxxxx Xxxxx, Xxxxxxxxxx xx Xxxxxxxxxxxx, Xxxxxxxx Xxxxxxxxxx Xxxxxxxx Institute, Xxxxxxx xx Xxxxxxxx Xxxxxxx Xxxxxxxx 666 Xxxxxxx Xxxx Xxxx, Xxxxxxx Xxxxxxx Xxxxxxxxxxx Xxxxxxxx Xxxxxxxxx, Jilin Čína |
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x) |
Xxxxxx xxx Xxxxxxxx xxxxxxxxxxxx XXX reference xxxxxxxxxx xx xxx Animal xxx Xxxxx Xxxxxxxxxx Xxxxxx 177 Hyeoksin 8-xx, Xxxxxxxx-xx, Gyeongsangbuk-do, 39660, Xxxxx Xxxxx |
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x) |
Xxxxxxx xxx Xxxxxxx Xxxxxxx xxx Xxxxxxxxxx Xxxxxx Xxxxxxxxxx 1600 Xxxxxxx Xxxx, XX, Xxxxxxx, XX 30333, Xxxxxxx státy xxxxxxxx |
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x) |
Xxx Xxxxxxxx Xxxxxxxxx of Xxxxxx Health 50/2 Xxxxxxxxxx, Xxxxxx, Chatuchak Xxxxxxx 10900 Xxxxxxx |
Xxxxxx 2
Toto xxxxxxxxxx xx určeno xxxxxxxx xxxxxx.
X Bruselu xxx 14. xxxxx 2020.
Xx Xxxxxx
Xxxxxx XXXXXXXXXX
xxxxxx Komise
(1) Úř. věst. X 79, 30.3.2000, x. 40.